Summary

The primary objective of this study is to determine the overall response rate to erlotinib
in patients with polycythemia vera (PV). Response rate will be assessed by improvement in
the complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is
purposed in this study to explore a possible molecular targeting of the driving mechanism of
PV.

Description

This is a phase II open-label study. Patients will be screened for MPN diagnoses and
patients with Polycythemia vera proven to have JAK2V617F mutation will be given the option
to enroll. Consenting patients will take erlotinib daily for 16 weeks. Blood work and
phamacokinetics will be drawn for serum level monitoring. Doses will be administered
according to side effects or held. First assessment will be at day 15 wth subsequent
assessments at 28 day intervals. Non-responders will be taken off the study and managed
according to standard of care. Patients who do respond will continue taking the therapy for
a total of 12 months. Observation will be for a total of 12 months after finishing
treatment. In addition to the clinical aspect of this study, there will be correlative
studies where molecular response will be checked and its correlation with clinical response.

We report the clinical case of a patient presenting with an acute myocardial infarction with ST- segment elevation. The patient is affected by polycythemia vera for many years and doesn't have any oth...

Polycythemia vera (PV) is a risk factor for systemic thromboses and ischemic stroke. This has been attributed to blood hyperviscosity, the result of increased blood cell production. Intravenous immuno...

Medical and Biotech [MESH] Definitions

Phlebotomy

The techniques used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders such as erythrocytosis, hemochromatosis, polycythemia vera, and porphyria cutanea tarda.

Polycythemia Vera

A myeloproliferative disorder of unknown etiology, characterized by abnormal proliferation of all hematopoietic bone marrow elements and an absolute increase in red cell mass and total blood volume, associated frequently with splenomegaly, leukocytosis, and thrombocythemia. Hematopoiesis is also reactive in extramedullary sites (liver and spleen). In time myelofibrosis occurs.

Erlotinib Hydrochloride

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

Polycythemia

An increase in the total red cell mass of the blood. (Dorland, 27th ed)

Trichechus Manatus

Member of the genus Trichechus inhabiting the coast and coastal rivers of the southeastern United States as well as the West Indies and the adjacent mainland from Vera Cruz, Mexico to northern South America. (From Scott, Concise Encyclopedia Biology, 1996)

More From BioPortfolio on "Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera"

Relevant Topics

RadiologyRadiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...

Clincial TrialsIn a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...